FDA Panel Recommends Over-the-Counter Sale of Allergy Drugs

GAITHERSBURG, Md. – Three popular allergy medications are safe enough to be sold without prescription, a federal advisory panel ruled Friday in an unprecedented case that could save the health insurance industry billions of dollars but increase costs for consumers.

Acting on a petition by Wellpoint Health Networks of Thousand Oaks, Ca., the Food and Drug Administration panel recommended that Claritin, Allegra and Zyrtec be made available over the counter, without supervision by a doctor.

The vote was 19-4 each for Claritin and Zyrtec, and 18-5 for Allegra. The FDA is not required to follow the recommendations of the panel, but usually does so.

The insurance company had argued that the allergy medications were safe.

"There is no clinical reason for Claritin, Allegra and Zyrtec to be maintained as prescription drugs," Robert Seidman, a vice president of Wellpoint Health Networks, told the 22-member panel. "Patients can safely use these drugs. They have side effects similar to a sugar pill."

But drug companies countered that the move would force consumers into a "risky trial-and-error gamble with their health, their quality of life and their money."

Many people will self-diagnose and treat conditions that need the attention of a doctor, company executives said.

Dr. Robert J. Spiegel, vice president of Schering-Plough, maker of Claritin, said prescriptions are needed to "protect and optimize the public health."

"Insurance companies see a physician visit as a cost item," said Spiegel. "We see it as an essential part of health care. Now is not the time to drive patients farther away from their physicians."

The financial implications of the FDA's decision will be huge for the insurance industry, drug manufacturers and consumers.

Last year, the three drugs generated about $4.7 billion in sales.

The drugs sell for about $2 a pill. With a prescription, a patient with insurance can get a month's supply at the personal cost of a copay charge, perhaps as little as $5. The insurance company then has to pay the balance, $50 to $60.

If the drugs are reclassified as over the counter, insurance companies would no longer have to pay for them. By some estimates, Wellpoint, with 10 million clients nationally, could save $45 million a year.

So for millions of people covered by health insurance, selling the medications over the counter would mean a greater expense, although it is widely expected that drug companies would be forced to lower prices to stay competitive with other drugs available without a prescription.

In Canada, for example, Claritin can be purchased at stores for significantly less than the U.S. price.

Drug manufacturers pointed to asthma, a serious respiratory condition, as a disease that patients might try to treat without seeing a doctor if the medications were available without a prescription.

Inappropriate treatment could have serious medical consequences, said Dr. Francois Nader, vice president of Aventis Pharma AG, maker of Allegra.

"Consumers would face a risky trial and error gamble with their health, their quality of life and with their money," he said.

Nader said the insurance company is pushing for declassification because it does not pay for over-the-counter drugs and the change could save the company millions of dollars.

But he predicted that "the short term gain to the insurers would increase the health care burden" on society.

Pfizer Incorporated, maker of Zyrtec, did not make a presentation at the meeting. The allergy drugs are known as second generation antihistamines because they dry up allergy symptoms without causing drowsiness so common with first generation over-the-counter drugs.

Claritin was approved in 1993, Zyrtec in 1995 and Allegra in 1996.

In response to the decision, shares of Schering-Plough finished trading on the New York Stock Exchange up $1.20 to $38.20. Shares of Aventis fell $1.22 to $75.53, while Pfizer was off 74 cents to $43.00.

Dr. Robert Meyer, of the FDA, said that an examination of the drug sales show that all three "have a good post marketing safety profile."

Meyer told the panel that there have been only a few instances of heart and kidney problems and seizures among patients taking the drugs, but there is no clear indication that these adverse events were directly caused by the medication.

In his presentation, Seidman said that second generation antihistamines are now on sale without a prescription in 17 countries.